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Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Omarigliptin
Sitagliptin
Placebo to omarigliptin
Placebo to sitagliptin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has type 2 diabetes mellitus

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Omarigliptin 25 mg (Phase A+B)

    Sitagliptin (Phase A) switching to Omarigliptin (Phase B)

    Placebo (Phase A) switching to Omarigliptin (Phase B)

    Arm Description

    Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)

    Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

    Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

    Outcomes

    Primary Outcome Measures

    Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24
    HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
    Percentage of Participants Who Experienced at Least One Adverse Event During Phase A
    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
    Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
    Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
    Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.

    Secondary Outcome Measures

    Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24
    Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
    Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24
    Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).

    Full Information

    First Posted
    October 5, 2012
    Last Updated
    August 15, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01703221
    Brief Title
    Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)
    Official Title
    A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 24, 2012 (Actual)
    Primary Completion Date
    April 25, 2014 (Actual)
    Study Completion Date
    April 25, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.
    Detailed Description
    The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    414 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Omarigliptin 25 mg (Phase A+B)
    Arm Type
    Experimental
    Arm Description
    Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
    Arm Title
    Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
    Arm Type
    Active Comparator
    Arm Description
    Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
    Arm Title
    Placebo (Phase A) switching to Omarigliptin (Phase B)
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
    Intervention Type
    Drug
    Intervention Name(s)
    Omarigliptin
    Intervention Description
    Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin
    Other Intervention Name(s)
    Januvia®
    Intervention Description
    Sitagliptin 50 mg tablet administered orally once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to omarigliptin
    Intervention Description
    Placebo to omarigliptin 25 mg capsule administered orally once weekly
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo to sitagliptin
    Intervention Description
    Placebo to sitagliptin 50 mg tablet administered orally once daily
    Primary Outcome Measure Information:
    Title
    Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24
    Description
    HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
    Time Frame
    Baseline and Week 24
    Title
    Percentage of Participants Who Experienced at Least One Adverse Event During Phase A
    Description
    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
    Time Frame
    Up to 24 weeks
    Title
    Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
    Description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
    Description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
    Time Frame
    Up to 24 weeks
    Title
    Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
    Description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
    Time Frame
    Up to 52 weeks
    Secondary Outcome Measure Information:
    Title
    Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24
    Description
    Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
    Time Frame
    Baseline and Week 24
    Title
    Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24
    Description
    Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
    Time Frame
    Baseline and Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has type 2 diabetes mellitus Exclusion Criteria: History of type 1 diabetes mellitus or a history of ketoacidosis History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    28449368
    Citation
    Gantz I, Okamoto T, Ito Y, Okuyama K, O'Neill EA, Kaufman KD, Engel SS, Lai E; the Omarigliptin Study 020 Group. A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1602-1609. doi: 10.1111/dom.12988. Epub 2017 Jul 6.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=3102-020&kw=3102-020&tab=access

    Learn more about this trial

    Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

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